Earnings Call Transcript - MIRM Q1 FY2026

Operator

Good afternoon, and welcome to Miram Pharmaceuticals' first quarter 2026 earnings conference call. My name is Tracy, and I will be your operator today. All lines are currently in a listen-only mode, and there will be an opportunity for Q&A after management's prepared remarks. If you would like to ask a question during that time, press star 1 to raise your hand. I would now like to hand the call, the conference, over to Andrew McKibben, SVP of Strategic Finance and Investor Relations. Please go ahead.

Andrew McKibben, Head of Investor Relations

Thank you, Tracy, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceuticals' first quarter 2026 earnings conference call. For our prepared remarks, I'm joined today by our Chief Executive Officer, Chris Peets, our President and Chief Operating Officer, Peter Radovich, and Eric Bierkolt, our Chief Financial Officer. Our Chief Medical Officer, Joanne Kwan, will be joining us for Q&A. Earlier this afternoon, Miriam issued a press release reporting our first quarter 2026 financial results. Copies of the press release and our SEC filings are available in the Investors section of our website. Before we start, I'd like to remind you that during the course of this conference call, we will be making certain forward-looking statements based on management's current expectations, including statements regarding Miriam's programs and market opportunities for its approved medicines and product candidates and financial guidance. These statements represent our judgment and knowledge of events as of today and inherently involve risks and uncertainties that may cause actual results to differ materially from the results discussed. We are under no duty to update these statements. Please refer to the risk factors in our latest Form 10Q and subsequent SEC filings for more information about these risks and uncertainties. With that said, I'd like to turn the call over to Chris.

Chris Peetz, CEO

Thanks, Andrew. And good afternoon, everyone. We have a number of important updates to cover today, but I'd like to start by grounding in the vision we set when we founded Merrim in 2018, building a company focused on bringing forward medicines for overlooked rare diseases. This quarter reflects the progress we've made in turning that vision into a durable, growing business. Our start was based on Livemarly, and today we are a broader rare disease company with three approved medicines in a pipeline position to deliver multiple new therapies over the next two years. These high-impact programs are grouped across two focus areas rare liver disease where we have built clear leadership and rare genetic disease where we are establishing a second growth platform each with distinct commercial capabilities across both we've built a financially self-sustaining business that can support continued investment in the portfolio our strategy is driving compelling results starting with rare liver disease uptake of Livmarly remains strong, driven in part by performance in PFIC, which continues to exceed expectations. Based on that demand and continued performance across all brands, we are raising our full-year revenue guidance to $660 to $680 million. More importantly, we are now seeing the next phase of our rare liver disease business take shape. Our recent clinical readouts in PSC and hepatitis delta represent important potential expansions for this business, extending beyond our pediatric foundation into larger patient populations with significant unmet need. In PSC, the VISTA study of Velixabat showed a significant improvement in pruritus, reinforcing the potential for Velixabat to play an important role for these patients who currently have no approved medicines. This is a major advance in PSC research and positions Velixabat as a potential first approved medicine for patients in the U.S. And in hepatitis delta, results from the phase 2B portion of the UZER1 study further support the potential for Brillova Tug in a patient population where treatment options are extremely limited. We look forward to the upcoming late-breaking presentations for both VISTAs and Azure at Easel later this month. Now, in parallel to this expansion of our rare liver disease business, today we are announcing another step in building out our rare genetic disease business with the addition of ZalurgoCertid, recently licensed from Insight. ZalurgoCertid is a once-daily oral ALK2 inhibitor in development for fibrodysplasia osifakams progressiva, or FOP, an ultra-rare progressive condition where patients develop bone and soft tissues. This accumulation of excess bone leads to profound physical immobilization, with most FOP patients becoming wheelchair-dependent by early adulthood, and severely impacts life expectancy. Based on the strength of Zalurga-Cirtib's progress study conducted by Insight, an NDA has been accepted with priority review, with a PDUFA date of September 26th this year. If approved, we expect to launch by year end. This is a strong strategic fit, aligning with our capabilities in rare genetic disease, where care is concentrated in a small number of specialized centers and requires deep engagement with patients, caregivers, and physicians. Stepping back, we've built a company with multiple commercial growth drivers, a pipeline of meaningful upcoming catalysts, and the financial strength to advance our portfolio independently. This foundation is translating directly into high-impact medicines for patients and into value creation as we deliver on our strategy. And with that, I'll turn the call over to Peter to walk through the commercial portfolio in preparation for the three upcoming potential launches.

Peter Radovich, COO

Thank you, Chris. The first quarter was another period of strong commercial execution with total net product sales of approximately $160 million. This included Livemarly net product sales of $84 million in the U.S. and $30 million internationally, with the bio-asset medicines contributing $46 million. Robust adoption in PFIC, particularly in adult patients, continues to be a strong point for Livemarly, as education to increase awareness and recognition of genetic toll stasis among adult liver providers continues to be successful. Additionally, we saw stronger than expected performance in Q1 international of Marley sales, as well as continued new patient ads and allergy worldwide. The bile acid medicines grew in a manner consistent with their cadence over the last several quarters, highlighted by our rare genetics team continuing to identify undiagnosed patients with CTX. Overall, we expect these dynamics to continue and as a result are raising our full year 2026 net product sales guidance to $660 to $680 million. And as Chris mentioned, we are also beginning to see the next phase of growth in our rare liver disease business take shape. The recent results from the VISTA study of Elixabat and PSC and the Azure 1 study of BarlovaTug and Hepatitis Delta represent important steps in extending our presence into larger, primarily adult liver settings where patients have limited or no approved treatment options. These programs build directly on a global commercialization platform we have established for Livmarly, Setextli, and Kolbaum, heavily leveraging our existing technologies, people, and infrastructure. We plan to expand our US and international teams starting later this year to reach liver healthcare providers in adult settings, including GI liver providers who manage PSC patients and hepatitis delta, as well as other care settings like infectious disease and selected primary care providers, where we believe we can increase the number of diagnosed hepatitis delta patients. In the U.S., our current 20-person liver field commercial team reaches about 1,500 healthcare providers, with currently focused on pediatric liver providers and some higher volume adult providers. After our planned expansion to approximately 60 U.S. field commercial personnel, we anticipate being able to reach over 4,000 liver healthcare professionals, representing the vast majority of potential prescribers for our rare liver business. Turning to our rare genetic disease business, we are very excited by the addition of Zalurga Sertic for the treatment of FOP, where there remains a desperate need for additional treatment options. FOP is a devastating, relentlessly progressive condition in which soft tissues, such as muscles, tendons, and ligaments, gradually turn into a second skeleton, leading to cumulative loss of mobility, severe disability, and early mortality. FOP is a highly concentrated, ultra-rare disease. with an estimated prevalence of about one per million, which translates to approximately 300 patients in the United States and around 900 patients globally. Patients with FOP are largely managed by specialized tertiary centers, with most of these centers also managing patients receiving cetextly and colbalm, allowing us to leverage our rare genetic disease team to commercialize salergocertive. And we've been impressed by the salergocertive data from the a pivotal PROGRESS study, in particular the secondary endpoints which form the basis of the NDA application, and we look forward to the presentation of the data from the PROGRESS study at an upcoming medical meeting. The NDA for Zalurga Sertib has been accepted for priority review by the FDA with a September 26, 2026 PDUFA date. If approved, we expect to launch Zalurga Sertib in the United States by the end of this year with expansion to additional countries starting in 2027. We are excited about the addition of the Lerga Sertiv, which we believe has the potential to become the cornerstone of our rare genetic disease business and reach peak sales of over $200 million. This high-impact medicine fits perfectly with our medical and commercial team's capabilities and passion for supporting patients suffering from ultra-rare diseases like FOP. And with that, I'll turn it over to Eric to review our financial results.

Eric Bjerkholt, CFO

Eric, and I give up on the team and the crew and disciplined investment behind our pipeline, which remains on track across all programs. Today, I'll walk you through the financials for the quarter, including an overview of the impact of the Blue Jay acquisition and the Zalogi circuit transaction. The net product sales for the first quarter were $160 million compared to net product sales of 112 million in the first quarter of last year cash cash equivalents and investments as of march 31st were 421 million compared with 391 million at the beginning of the year in the first quarter the cash contribution margin from our commercial business was in the mid-50s percent and cash flow from operations was about 2 million first quarter financials were significantly impacted by one-time expenses related to the acquisition of Blue Jay Therapeutics which closed in January of this year. The total net cash outflow related to this acquisition was $253 million which was offset through net financing proceeds of approximately $260 million. Total operating expense for the quarter ended march 31st was 949 million which includes 761 million in expense associated with the acquisition of blue jay r d expense of 98 million sgna expense of 96 million and cost of sales of 29 million expenses for the quarter included stock-based compensation intangible amortization and other non-cash expenses of $64 million, including $35 million of stock-based compensation expense associated with the acquisition of Blue Jay. The intangible amortization and other non-cash IRDM expenses are largely reflected in our companies. As Chris and Peter mentioned, we recently entered into an exclusive license agreement with Insight. In return for worldwide rights to the lower asserted, InSight receives an upfront payment of $16 million and is eligible to receive additional development and regulatory milestone payments, including $25 million upon U.S. FDA approval for FOP, ownership of a rare pediatric disease priority review voucher, if awarded, as well as sales-based milestones and shared royalties on worldwide net sales in the mid to high single digit percent range as we've discussed previously we expect r d expense to step up in 2026 as we invest behind berlovitag ahead of the anticipated bla submission next year for example r d expense in the first quarter included 21 million related to the development of berlovitag importantly this expense expected increase is fully funded we are continuing to scale the business with discipline balancing investment in growth with a strong balance sheet and financial independence this approach positions us to advance our pipeline and execute on upcoming milestones without compromising our long-term financial strength i'll now turn the call back to chris for closing remarks. Thanks, Eric.

Chris Peetz, CEO

Miram's in a strong position after a very busy start to the year. What is most encouraging about the quarter is not just the number of positive updates, but how clearly they fit together. We continue to grow our commercial medicines. We're expanding our rare liver business into larger indications. We've added what we believe is a transformational medicine to our rare genetic business. And importantly, this is all coming together within a high-impact, scalable business model. We're excited about the progress ahead as we approach multiple pivotal readouts, potential regulatory submissions, and potential new product launches. I'd also like to thank the entire Miram team for all the hard work in getting us where we are today. Your dedication brings new treatment options to patients around the world. With that, operator, please open the call for questions.

Operator

We will now begin the question and answer session. If you would like to ask a question, please press star 1 to raise your hand. To withdraw your question, press star 1 again. We ask that you pick up your handset when asking a question to allow for optimum sound quality. If you are muted locally, please remember to unmute your device. Please stand by now while we compile the Q&A roster. Your first question comes from the line of Gavin Clark Gartner with Evercore ISI. Your line is open. Please go ahead.

Yasha, Analyst — Evercore ISI

Hi, this is Yasha on for Gavin. I just had one on FOP. Wondering your current view on the number of diagnosed FOP patients in the U.S. based on claims, patient advocacy, and provider research, and then how many of those patients will immediately be treatable at launch?

Peter Radovich, COO

And then I have one follow-up on with Marley. Yeah, thanks for the questions. Yeah, we point towards the approximately 300 identified patients in the U.S. coming from a patient SNAPC group, IFOPA. In terms of addressable patients, you know, probably the main feature there is the NDA application inside filed us for age 12 and over. So that'd be the main piece to consider, which would be the majority of the prevalent patients. And then in terms of those

Yasha, Analyst — Evercore ISI

Marley specifically on the guidance rates, wondering what's kind of driving the bulk of that increase. Is it due to the XUS expansion or kind of the continued PFIC ramp? And within PFIC is the contribution still skewing towards those older patients? Yeah, thanks for the question.

Peter Radovich, COO

I mean, certainly Livmarly US PFIC was the biggest driver and continue to see both pediatric and adult patients come to treatment. I think the older adolescents and adults really is the major driver, although we think still in early innings, we've made good progress educating adult providers on genetic testing, but probably still the minority of them are actually doing that. So I think there's probably more adult patients to find out there potentially benefit. And yes, on the

Chris Peetz, CEO

international piece, you know, Q1, historically, we've seen a bit more seasonality and a little bit of a softer number in Q1. And that just wasn't as much of a factor this year, somewhat in part of not only additional countries performing, but also PFIC starting to show up in that

Operator

international number. Thank you. Thanks for the questions. Your next call comes from the line of Josh Shimmer with Cantor. Your line is open. Please go ahead.

Josh Shimmer, Analyst — Cantor Fitzgerald

Thanks so much for taking the questions. Also on Zalurgis, Sertib, how are you thinking about its differentiation versus maybe some of the other programs in development? Gretas, so Gretas, Matt, if I'm pronouncing that right, and Soho Knows, that's number one. Number two, are you planning to explore the program in other ossification indications, disorders. And then number three, I think I heard you say peak sales for the asset of 200 million. Is that global or U.S.? Thank you. Thanks, Josh, for the questions. Yeah,

Chris Peetz, CEO

just to clarify that peak, that 200 plus is a global number for us. And in terms of kind of positioning here, the programs that you covered there, those are the ones that we're tracking, SOHONOS being approved, and the other program being in registration phase. And for SOHONOS, you know, the data coming out of the progress study here for Zalerg Assertive is a real step forward in terms of the overall activity profile and tolerability and safety profile. So, we see the clinical data here being a quite meaningful advance on what's currently available in the market, which has quite a few limitations to it. And then compared to the pipeline, this is an oral, which we see as a big advantage, and particularly in this setting where you can potentially drive ossifications from injections and some of these other interventions. So having an oral, we see as a nice differentiator for the program.

Josh Shimmer, Analyst — Cantor Fitzgerald

Got it. And then plans for other ossification disorders?

Chris Peetz, CEO

you know we still early days in thinking about it uh you know at this point want to stay very focused on getting this launched for fop but it's certainly something we'll consider as we

Operator

get further down the road thanks very much thanks for questions your next call comes from the line of john wolenbin with citizens your line is open please go ahead hey thanks for taking the question

John Wolleben, Analyst — Citizens JMP

You know, a little unusual having something under view or haven't seen any of the data for it. Just wondering what you guys have been privy to to make you comfortable with this acquisition, and then, you know, what would be the form for it to make sense to get this out into the public domain?

Chris Peetz, CEO

Yeah, thanks for the question, John. I fully appreciate the uniqueness of the situation. You know, in our review, this is a conversation that's actually been going on for quite some time. It's typical for a licensed transaction like this. So, we've had full access to clinical data, to the regulatory correspondence, and the NDA. So, we feel quite confident in the profile for Zoolog Assertib and where they're at in the regulatory process. From the Insight side, where they've done a fantastic job putting together this program and saw it, you know, fitting better in a rare disease company like Mirim, but the work they've done on it is they want to have the data presented first at a medical meeting. So we're hopeful that's happening relatively soon. So once we get that presented, we'll be able to share more on the pivotal data

John Wolleben, Analyst — Citizens JMP

and overall product profile. And will you guys be eligible for a pediatric review voucher

Chris Peetz, CEO

if approved? So we do expect this to be eligible for a voucher. Under the terms of the agreement, Insight will keep that voucher and we will launch the product. So the way operationally this works is Insight is kind of given their mid-stride with the filing and review, they'll complete and then will take over sponsorship at the point of U.S. approval. Thanks, Chris.

Operator

Your next question comes from the line of Mike Ohles with Morgan Stanley. Your line is open. Please go ahead.

Rohit, Analyst — Morgan Stanley

Hi, this is Rohit on for Mike. Thanks for taking our questions. With the recent pipeline acquisitions, can you talk about how you're thinking about BD moving forward? And then also, can you just talk about how you're thinking about pricing in FOP?

Chris Peetz, CEO

I can start my head over to Peter, but I think as you've seen now from Miriam, kind of over the the history of the company um we see a priority in staying active on front that's how you find unique opportunities that fit and add value to the company uh so we will continue to uh to work to find good programs to bring into the team uh maybe have peter kind of touch on the any more on that or the second part of the question

Peter Radovich, COO

yeah i mean nothing more on the the bd strategy on those lower assertive uh pricing obviously we'll make a decision and communicate that, you know, closer to approval. But just, you know, I think for thinking about a U.S., I mean, you can look at the Neiman-Pick seed products and other ultra-rare settings like that where you have a strong value proposition and similar happy is probably

Operator

get you in the ballpark. Your next question comes from the line of James Condilis with Stiefel.

James Condilis, Analyst — Stifel

Your line is open. Please go ahead. Hey, thanks for taking my question and congrats on the order. Sure. You know, maybe one follow-up on HDV, I think, you know, where we've heard a couple questions is maybe in the 900-MIG monthly arm, specifically as it relates to, you know, the TND virologic response, and maybe a little bit of an outlier relative to, like, some of your prior data and other, you know, the rest of your sort of data set. Just, like, curious your perspectives here, and, you know, as you think about the, you know, commercial opportunity here, for docs in the real world, what do you think is kind of the most important measure as it relates to, you know, evaluating efficacy for these different drugs? Is it that, you know, T and D, Virologic response, other measures of Virologic response, the composite, you know, just curious your perspective there. Thanks.

Chris Peetz, CEO

Yeah, thanks for the question. I'll maybe make a couple comments and have Joanne speak to some of the data that we're seeing out of the 01 Phase II portion. And I think in terms of what we're, you know, focused on what we think is most relevant for ultimate use and driving adoption here is that composite of virologic response and ALT normalization. Those two factors are really what's pointed to in the FDA guidance and shows that you're not only addressing the viral load, but you're also addressing the liver inflammation that is part of the disease. So seeing both of those move means you're kind of going after both components of the, both of the considerations for both the infection and the liver. Maybe I'll ask Joanna to touch on the data we've seen to date.

Joanne Quan, Other

Yeah, and so, you know, Chris is talking about the composites, you know, all very true. When we look at the, you know, curves in terms of the virological response, we do see declines in everyone. So, you know, when you structure the endpoint, if you don't meet a certain point by week 24, then you're either on one side of line or the other. But we do see decreases in all of the patients. There's certainly no evidence of lack of response or resistance or anything like that. So really, you know, partly it's an artifact of time. We do see deepening response with continued treatment. You know, and again, this is a fairly small, numerically fairly small group. We'll have a lot more information with the full Azure I and Azure IV phase three data sets to make a final call on that.

James Condilis, Analyst — Stifel

Makes sense. Thank you. Thanks for the question, James.

Operator

Your next question comes from the line of Brian Scorny with Baird. Your line is open. Please go ahead.

Brian Skorney, Analyst — Baird

Hey, good afternoon, guys. Thanks for making my question and great quarter. I guess I'd love to also ask a question on FOP, too. It seems like you're doubling down on making it your corporate nemesis. So I'm just wondering if you could kind of give your broad thoughts on where you think Sohonis' profile leaves an opportunity for another entrant and compare and contrast how Ziller might address these. And the timeline would put us right around mid-cycle review with the FDA right now. So I'm just wondering if you could say if that has already happened or is still pending.

Chris Peetz, CEO

Yeah, thanks for the question. On the review, yes, that has happened. And I'd just say things are tracking as expected. But maybe I'll ask Peter to comment a little bit more on positioning.

Peter Radovich, COO

Yeah, and I think certainly the feedback we've heard from, you know, stakeholders, patients, caregivers, physicians, others, available therapy in the market today, you know, there's just, there's a lot to be desired, you know, in terms of both efficacy and safety. We'll have to be able to get into more details once we have the product data presented at an upcoming medical conference. But from what we've seen in our review, there's a little conservative profile, really exciting about what it can mean for these patients, both efficacy-wise

Operator

as well as a convenient oral. Okay. Thank you. Your next question comes from the line of Lisa Walter with RBC Capital. Your line is open. Please go ahead.

Lisa Walter, Analyst — RBC Capital Markets

Oh, great. Thanks so much for taking our question. Maybe just some more detail if you can share on the opportunity for FOP. Are there any overlap with your current call points? And did you disclose the deal terms with Insight? And maybe just one more, you know, given the recent positive of results in HEPTI and PSC. Wondering if this has impacted your thinking on when Mirum could become a profitable company. Thanks so much for taking our questions.

Chris Peetz, CEO

Yeah, maybe I'll ask Peter to kind of speak to the SOP points and then have Eric kind of give some financial forward-looking views.

Peter Radovich, COO

Yeah, great overlap with our existing team, our rare genetics team that's focused on Texley-Colbomb. We mentioned that, you know, the majority, the significant majority of the FOP patients, FOP patients, are cared for in settings centers that also prescribe Cetextli and Colbomb. Different prescribers most of the time. Some overlap in medical genetics. FOP has, you know, the biggest prescriber there will be endocrinologists. So that's a new kind of physician target, but the center overlap is really high with our existing rare chance business. So Sadi is about adding this product to that team.

Eric Bjerkholt, CFO

Yeah, and then on the financials, we did disclose the upfront license fee was $16 million, and then the next milestone would be $25 million upon FDA approval. There's some other commercial milestones, but also royalty in low to, well, mid to high single-digit range. And we expect after launch that this product will be accretive very, very quickly. But your question was also about the path to profitability, and I think that's much more driven by Brilovitug and Volixibat, as well as our current commercial business. As we've said, we're spending a lot on R&D this year for both of those products. And so profitability will be, you know, pushed out probably until 28 on the gap basis.

Chris Peetz, CEO

We're going to reiterate that they're expected to be operating cash flow positive next year.

Operator

Your next question comes from the line of Jessica Fye with J.P. Morgan. Your line is open. Please go ahead.

Jessica Fye, Analyst — J.P. Morgan

Hey, guys. Good afternoon. Thanks for taking my question. Can you estimate the contribution to first quarter Livmarly sales from Allergeal versus PFIC? And then another one, FOP, just thinking about that market, what do you see as the penetration for palaveratine, and would you envision the ALK being used in combination with that drug?

Chris Peetz, CEO

Just for the questions, I mean, just briefly on Livmarly, you know, we typically aren't breaking out by indication, but what we can say is that PFIC is, they're both growing, the PIFIC is the bigger growth driver maybe it's past the FOP question over

Peter Radovich, COO

the theater yeah and when we look at the US the market where this medicines available calaveratine you know it's probably a minority of diagnosed patients that are currently receiving it and see for pharmacy claims data and that kind of you know matches what we've heard in physician and caregiver interviews you know can be tried but it can often be difficult to tolerate and

Operator

stay on. Thank you. Thanks for the question. Your next question comes from the line of Manny Forhar with Lyrnick Partners. Your line is open. Please go ahead.

Ryan, Analyst — Ladenburg Thalmann & Company

Hey, guys. You have Ryan on for Monty. Thanks for taking our question and congrats on the quarter. Maybe just circling back to FOP, what's the latest thinking here on an OUS filing and when you guys would expect to launch there? And then just going back to the peak sales of $200 million, And we're just wondering, is that in a 12-plus age group that you guys would get approved in in the upcoming? And how should we think about upcoming data for the younger age groups that are being tested?

Chris Peetz, CEO

Thanks for the questions, Ryan. On XUS strategy, actually, a European filing is upcoming, so we could actually still have that in this quarter. Insight is still driving those activities. And, again, their team's doing a great job. In terms of the overall peak estimate, that 200 million plus, that's the full brand in FOP over life cycles, the way we look at it. The younger age patients, we do expect that the label would launch with the 12 and older. There are two other cohorts in the study that are ongoing that would support potentially taking that age lower over the near term, frankly. So those are ongoing and rolling now, so they're not too far out.

Operator

Thanks. Your next question comes from the line of Ryan Deschner with Raymond James. Your line is

Ryan Deschner, Analyst — Raymond James

open. Please go ahead. Thanks for the question. A couple for me. You know, what's your strategy for identifying FOP patients in the U.S. and abroad and addressing the relatively high misdiagnosis rate for FOP? And do you anticipate any early line of sight into a substantial duplication from insights prior clinical studies or maybe a combustion use program or something like that in fob and have a follow-up thanks for the question ryan yeah the um you know i think that

Peter Radovich, COO

the fob patients often have a longer diagnostic odyssey than they did they should um you know there are patients get diagnosed at birth but often the i think the literature says average age of diagnosis is seven years and it's obviously people that wait longer than that i think that's improved with availability of genetic testing um but you know that that's i think an opportunity to continue to raise awareness just like all of our rare genetic diseases to try to shorten that uh diagnostic uh odyssey as much as as much as we can we think we do think in the u.s though uh most of the you know a pretty substantial majority of the the patients are identified uh with that but we probably different story uh and and um you know middle and lower income

Ryan Deschner, Analyst — Raymond James

countries okay did you have a follow-up brand yeah i just was also wondering if there was anything notable so far in the business um extension in terms of um rollover discontinuation shooting rates, pruritus, or other patient metrics that might take a little longer to modulate over time?

Peter Radovich, COO

Yeah, I mean, Insight does have this progress study. It's enrolling well. I think we'll be able to disclose more about what they've seen from that at the upcoming medical conference. But it certainly seemed a lot of physician and patient interest in them.

Ryan Deschner, Analyst — Raymond James

Okay, thanks very much.

Operator

Your next question comes from the line of Joseph Tome with T.D. Cohen. Your line is open.

Joseph Tom, Analyst — TD Cowen

Hi, there. Good afternoon. Thank you for taking my questions. Maybe one on FOP. I guess the level of L2 inhibition you're seeing with the therapy, I guess, do you think that could be enhanced by geratosmab, Regeneron's activin A drug, or are these largely just going to be competitive therapeutics in the landscape? And then second, when we think about the potential expansion opportunity for Livmarly and the basket trial that's going to be reading out later this year, I guess, how should we think about that? In your overall projection for Livmarly, how much is this basket population? Thank you.

Chris Peetz, CEO

I can make a quick comment on the geratosumab positioning. And it's probably best to get into more detail on this after our data is presented so we can give a better, a more complete picture. But we think the profile for Zolugacertib and its clinical positioning is really strong as a convenient oral single agent and excited about bringing that that forward maybe a peter take a

Peter Radovich, COO

follow-up yeah and expand uh you know we've kind of talked about that uh that indication uh uh being about a third of the at least one billion peak sales uh opportunity for live marlin and still still reiterate that thank you thanks for the question your next question comes from the

Operator

line of Charles Wallace with HCW. Your line is open. Please go ahead. Hi, this is Charles. I'm

Charles Wallace, Analyst — HC Wainwright & Co.

for RK. Thanks for taking my question. So for FOP, another question on that. How many patients from the PROGRESS study, I think there was 63 in that study, do you expect could come on after launch? And do you expect to have some sort of bridging program? Thanks for the question, Charles.

Chris Peetz, CEO

you know and given the uh kind of the nature of the relationship here we're going to wait until we have the that data presented to give some of the detail on it um overall i think it's a really compelling profile and the feedback has been positive but just don't want to get into specifics um ahead of uh having that data presented okay that's fair and then i guess another question

Charles Wallace, Analyst — HC Wainwright & Co.

that may on the salesforce expansion so um you're growing it to uh 60 um in the field And I just wanted to maybe get a little more color on when you expect the team to be fully on board, and also when you expect them to be fully functional.

Peter Radovich, COO

You know, I kind of prepared a comment with starting later this year, and so I kind of think, you know, early next year we'd be kind of fully on board. And that team would, you know, cover both pediatric and adult settings where, you know, not just Allergeol and adult PEPIC can be found, but also, you know, PSC and Delta. So, I think by early next year, they'd be active in all those areas. And, of course, with the pipeline products, the activity would really start upon potential FDA approval.

Charles Wallace, Analyst — HC Wainwright & Co.

Thanks for taking my questions, and congrats to the next quarter.

Chris Peetz, CEO

Thanks. Thanks for the questions.

Operator

There are no further questions at this time. I would now like to turn the call back to Chris

Chris Peetz, CEO

Peets for closing remarks. Starts of 2026. Have a great afternoon.

Operator

This concludes today's call. Thank you for attending. You may now disconnect.